nordihydroguaiaretic acid in treating patients with nonmetastatic relapsed prostate cancer

Conditions: Prostate Cancer

Summary: rationale: nordihydroguaiaretic acid may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. purpose: this phase i trial is studying the side effects and best dose of nordihydroguaiaretic acid in treating patients with nonmetastatic relapsed prostate cancer.

objectives: primary * determine the maximum tolerated dose of nordihydroguaiaretic acid (ndga) in patients with nonmetastatic, biochemically relapsed prostate cancer. secondary * determine prostate-specific antigen-modulating effects of ndga in these patients. outline: this is a dose-escalation study. patients receive oral nordihydroguaiaretic acid (ndga) twice daily on days 1-28. treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of ndga until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. projected accrual: a total of 30 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed prostate cancer, meeting 1 of the following criteria: * androgen-dependent disease (testosterone ≥ 250 ng/ml) * androgen-independent disease (testosterone \< 50 ng/ml) * received prior definitive therapy for primary prostate cancer comprising any of the following: * external-beam radiotherapy with or without hormonal therapy * brachytherapy with or without pelvic external-beam radiotherapy or hormonal therapy * radical prostatectomy with or without adjuvant or salvage radiotherapy * cryotherapy * must have evidence of disease progression, as evidenced by elevated prostate-specific antigen (psa) that has risen serially from post-definitive therapy nadir on 2 determinations taken ≥ 1 week apart * elevated psa, meeting 1 of the following criteria: * at least 1.0 ng/ml post radiotherapy or cryotherapy * at least 4 ng/ml post radical prostatectomy * must show disease progression after discontinuation of the antiandrogen (for patients with androgen-dependent disease receiving antiandrogen as part of primary androgen ablation) * no metastatic disease, confirmed by negative bone scan and negative ct scan or mri of abdomen/pelvis patient characteristics: * karnofsky performance status 70-100% * absolute neutrophil count ≥ 1,500/mm³ * hemoglobin ≥ 8.0 g/dl * platelet count ≥ 100,000/mm³ * creatinine ≤ 1.5 times upper limit of normal (uln) * bilirubin ≤ 1.5 times uln * ast ≤ 1.5 times uln * no other medical condition that would interfere with study therapy or compliance * no other active malignancy except previously treated squamous cell or basal cell skin cancer or cancer that has been treated and considered to be at \< 30% risk of relapse * fertile patients must use effective contraception prior concurrent therapy: * see disease characteristics * more than 8 weeks since prior strontium-chloride sr 89 * more than 4 weeks since first dose of bisphosphonates * more than 4 weeks since prior major surgery or radiotherapy * at least 4 weeks since prior hormonal agents, including megestrol or steroids * concurrent luteinizing hormone-releasing hormone analogs allowed to maintain castrate levels of testosterone * at least 4 weeks since prior and no concurrent saw palmetto, finasteride, or any herbal agent intended to lower psa * prior adjuvant or neoadjuvant androgen-deprivation therapy allowed for androgen-dependent prostate cancer provided that all of the following are met: * no more than 8 months of androgen deprivation * at least 12 months since last day of effective androgen deprivation * testosterone \> 250 ng/ml at enrollment * prior hormonal therapy, chemotherapy, or investigational therapy for biochemical relapse allowed * no concurrent chemotherapeutic, immunotherapeutic, or other investigational agents * no concurrent radiotherapy * no concurrent filgrastim (g-csf) or sargramostim (gm-csf)

Keywords: recurrent prostate cancer stage iib prostate cancer stage iia prostate cancer stage iii prostate cancer stage i prostate cancer